CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 162 enrolled
Drug / intervention
Child(ren) receive an adult-onset result +5 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03832985
NCT03832985Early Ph 1Completed
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Reporting Adult-Onset Genomic Results to Pediatric Biobank Participants and Parents

Geisinger Clinic·interventional·Posted Feb 6, 2019·Updated Apr 9, 2026

In Brief

A Early Phase 1 clinical trial evaluating Child(ren) receive an adult-onset result, Child(ren) received a pediatric-onset result, and 4 other interventions for Hereditary Breast and Ovarian Cancer Syndrome and 2 related conditions. Completed, enrolled 162 participants across 1 site.

Detailed Summary

The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among MyCode adolescent participants and their parents, and health behaviors of children who received an adult- or pediatric-onset genomic result. Data will be gathered via quantitative surveys using validated measures of distress, family functioning, quality of life, body image, perceived cancer/heart disease risk, genetic counseling satisfaction, genomics knowledge, and adjustment to genetic information; qualitative interviews with adolescents and parents; and electronic health records review of children's initiation of risk reduction behaviors. The investigators will also conduct empirical and theoretical legal research to examine the loss of chance doctrine and its applicability to genomic research.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, Familial Hypercholesterolemia
CountriesUnited States
CollaboratorsNational Human Genome Research Institute (NHGRI)

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 6, 2019
Enrollment StartNov 25, 2020
Primary CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.4 years ago

Interventions

Child(ren) receive an adult-onset resultgenetic

Assess the psychosocial outcomes and the lived experience of MyCode parents whose child(ren) have received an adult-onset genomic result.

Child(ren) received a pediatric-onset resultgenetic

Assess the psychosocial outcomes and the lived experience of MyCode parents whose child(ren) have received an pediatric-onset genomic result.

Control - Negative Resultgenetic

Assess the psychosocial outcomes and the lived experience of MyCode parents whose child(ren) tested negative for the familial genetic variant.

Adolescents who received adult-onset resultgenetic

Psychological outcomes among adolescents who received an adult-onset result

Adolescents who received a pediatric-onset resultgenetic

Psychological outcomes among adolescents who received a pediatric-onset result

Adolescent controls - negative for familial variantgenetic

Psychological outcomes among adolescents who tested negative for the familial genetic variant